When a Small Process Failure Becomes a Patient Safety Event

by | Mar 23, 2026 | Analysis, Editorial, ISO 14971, Med-Devices, Product Design, Product Quality, Products_Devices, QMSR, Quality system, Reg_Information, Reg_Products, US-FDA

Medical Device Safety Alert Erbe cryoprobes may rupture or burst Home About Consumer Food and Beverage Supplements Regulatory Medical Devices Pharma Biologics Combination Products Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact What the...

Adulterated Supplements and the Limits of Post-Market Oversight

by | Mar 15, 2026 | Consumer Information, Consumer Safety, Dietary Supplements, Editorial, FDA Safety Communication, Industry Information, Labeling, Safety, Unapproved Drugs, US-FDA

Honey-Based Dietary Supplements Recalled Sildenafil and tadalafil not declared on product labeling Home About Consumer Food and Beverage Supplements Regulatory Medical Devices Pharma Biologics Combination Products Veterinary AI Quality QMSR Central News Enforcement...

Testosterone Regulation Takes a Sharp Turn

by | Dec 18, 2025 | Alerts-Pharma, Analysis, Consumer Information, Consumer Safety, Editorial, FDA Policy, FDA Regulations, Hormones, Industry Information, Industry News, Product Safety, Products_Drugs, Regulatory_Info

Testosterone Regulation Takes a Sharp Turn Why FDA’s December panel raises red flags Home Request Info QMSR Central QMSR FAQs ISO 13485 Transition Impact Integration Definitions FDA and ISO 13485 ISO 9000 Small Manufacturers Why FDA’s December Panel Raises Red Flags...

Do Not Blame FDA for Lax Oversight of Dietary Supplements 

by | Dec 13, 2025 | Dietary Supplements, DSHEA, Editorial, FDA Enforcement, Industry Information, Industry News, Legislation, MedWatch-System, Product Quality

Do Not Blame FDA for Lax Oversight of Dietary Supplements MDP Policy Commentary Home Request Info QMSR Central QMSR FAQs ISO 13485 Transition Impact Integration Definitions FDA and ISO 13485 ISO 9000 Small Manufacturers A Regulatory System Designed to Fail  The recent...